Aliskiren for Immunoglobulin A (IgA) Nephropathy

This study has been completed.

Sponsor:

Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00870493

First Posted: March 27, 2009

Last Update Posted: December 4, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA nephropathy, which has no specific treatment at present.

each subject will receive oral aliskiren 300 mg/day for 16 weeks, followed by a washout period of 4 weeks, then crossed over to placebo for another 16 weeks

Drug: Aliskiren

Aliskiren 300 mg daily oral

Drug: Placebo

starch tablet, 300 mg/day

Active Comparator: II

each subject will receive placebo for 16 weeks, followed by a washout period of 4 weeks, then crossed over to oral aliskiren 300 mg/day for another 16 weeks

Drug: Aliskiren

Aliskiren 300 mg daily oral

Drug: Placebo

starch tablet, 300 mg/day

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

aged 18-65 years

requires anti-hypertensive therapy

renal biopsy within the past 3 years and confirmed the diagnosis of IgA nephropathy